Automated insertion device

ABSTRACT

A device for insertion of a medical tool held in an end effector, the device comprising moveable platforms providing motion in two generally orthogonal directions, and two piston mechanisms operating within cylinders, coupled to the moveable platforms, and being attached at their distal end to the end effector by means of a common joint. The pistons may be linear actuators. The end effector is manipulated by driving mechanisms propelling the pistons linearly. The proximal ends of the cylinders may be coupled to a common shaft. The axes of the cylinders and the pistons, the line connecting the pistons axes through the common joint and the axis of the cylinders&#39; common shaft may all be located substantially in a single plane. Coordinated motion of the moveable platforms and the piston mechanisms enables the maintenance of a virtual remote center of motion of the medical tool as its orientation changes.

RELATED APPLICATIONS

This application is a National Phase of PCT Patent Application No.PCT/IL2017/050584 having International filing date of May 25, 2017,which claims the benefit of priority of U.S. Provisional Application No.62/341,097 filed on May 25, 2016. The contents of the above applicationsare all incorporated by reference as if fully set forth herein in theirentirety.

FIELD OF THE INVENTION

The present invention relates to the field of interventional procedures,and specifically to devices, systems and methods for automated insertionof a medical tool into a target within the body of a subject.

BACKGROUND

Many routine treatments employed in modern clinical practice involvepercutaneous insertion of medical tools, such as needles and catheters,for biopsy, drug delivery and other diagnostic and therapeuticprocedures. The aim of an insertion procedure is to place the tip of anappropriate medical tool safely and accurately in a target region, whichcould be a lesion, tumor, organ or vessel. Examples of treatmentsrequiring insertion of such medical tools include vaccinations,blood/fluid sampling, regional anesthesia, tissue biopsy, catheterinsertion, cryogenic ablation, electrolytic ablation, brachytherapy,neurosurgery, deep brain stimulation and various minimally invasivesurgeries.

Guidance and steering of needles in soft tissue is a complicated taskthat requires good three-dimensional coordination, knowledge of thepatient's anatomy and a high level of experience. Therefore,image-guided automated (e.g., robotic) systems have been proposed forperforming these functions. Among such systems are those described inU.S. Pat. No. 7,008,373 to Stoianovici, for “System and method for robottargeting under fluoroscopy”, U.S. Pat. No. 8,348,861 to Glozman et al,for “Controlled Steering of a Flexible Needle”, U.S. Pat. No. 8,663,130to Neubach et al, for “Ultrasound Guided Robot for Flexible NeedleSteering” and U.S. patent application Ser. No. 15/027,439 to Glozman etal, for “Gripper for Robotic Image Guided Needle Insertion”.

In recent years, body mounted automated devices have been introduced.Some of these devices are guiding devices that help in choosing theinsertion point and in aligning the needle with the insertion point andwith the target, and the physician then inserts the needle manually.Others are steering devices that also insert the needle towards thetarget, as disclosed, for example, in U.S. Application Publication No.2006/0229641 to Gupta et al, for “Guidance and Insertion System”, U.SApplication Publication No. 2009/0112119 to Kim, for “Rotating BiopsyDevice and Biopsy Robot”, U.S. Application Publication No. 2014/0371584to Cleary et al, for “Patient Mounted MRI and CT Compatible Robot forNeedle Guidance in Interventional Procedures”, and U.S. PatentApplication Publication No. 2016/0249990 to Glozman et al, for “NeedleSteering by Shaft Manipulation”.

However, there is still a need for an automated insertion device whichis capable of steering a medical tool into a target within the patient'sbody accurately and reliably, and which provides a large angularworkspace for the medical tool while maintaining a low-profile workspacefor the insertion device.

The disclosures of each of the publications mentioned in this sectionand in other sections of the specification, are hereby incorporated byreference, each in its entirety.

SUMMARY

The present disclosure describes new exemplary automated systems anddevices for insertion of medical tools (e.g. needles) into a subject'sbody for diagnostic and/or therapeutic purposes.

In some implementations, an insertion system is disclosed, whichincludes an insertion device, a processor and a controller. Theinsertion system may be configured to operate in conjunction with animaging system. The utilized imaging modality may be any one of X-rayfluoroscopy, CT, cone beam CT, CT fluoroscopy, MRI, ultrasound, or anyother suitable imaging modality.

The processor may be configured, inter alia, to receive, process andshow on a display images from an imaging system (e.g., CT, MRI), tocalculate the optimal pathway for the medical tool (e.g., needle) froman entry point to the target while avoiding obstacles en route, and toprovide instructions to steer the needle toward the target according tothe calculated optimal pathway. In some implementations, needle steeringis controlled in a closed-loop manner, i.e., the processor generatesmotion commands to the insertion device via the controller and receivesfeedback regarding the actual location of the needle, which is then usedfor real-time pathway corrections. The optimal pathway, as well aspathway corrections, may be calculated and executed either on atwo-dimensional plane or in the three-dimensional space. In someimplementations, the entry point, the target and the obstacles, such asbones or blood vessels, are manually marked by the physician on one ormore of the obtained images.

Automatic needle insertion and real-time steering has many advantagesover manual needle insertion. For example, it obviates the need towithdraw and re-insert the needle, as is often required when thephysician manually inserts the needle and fails to reach the target, forexample, due to tissue movement as the needle is being inserted into thebody. Also, automatic needle steering improves the accuracy of theprocedure, which enables reaching small targets, thus allowing earlierdetection of malignant neoplasms, for example. In addition, it providesincreased safety for the patient, as there is a significant lower riskof human error. Further, such a procedure is safer for the medicalpersonnel, as it minimizes their radiation exposure during theprocedure. Since the automated device can be controlled from a remotesite, even from outside of the hospital, there is no longer a need forthe physician to be present in the procedure room.

In some implementations, the insertion device comprises at least onemoveable platform, two piston mechanisms coupled to the at least onemoveable platform, and an end effector, to which the medical tool iscoupled, either directly or by means of an insertion module. Each pistonmechanism may include a cylinder, a piston positioned, at least in part,within the cylinder, and a driving mechanism configured to propel thepiston in and out of the cylinder in order to manipulate the endeffector. In some implementations, the distal ends of the two pistonsmay be coupled to a common joint, and the proximal ends of the cylindersmay be coupled either to a common shaft or each to a separate shaft. Insome implementations, the cylinders, pistons, the pistons' common jointand the cylinders' shaft/s are all located substantially in a singleplane, allowing larger angular movement and thus a larger workspace forthe insertion device's end effector and medical tool. It can beappreciated that the cylinders, pistons, pistons' common joint andcylinders' shaft/s being located substantially in a single plane, mayspecifically refer to the axes (i.e., longitudinal axes) of thecylinders, pistons and cylinder shaft/s, and the line connecting betweenthe pistons' axes through the common joint, all being located in asingle plane. In some implementations, the axis of the cylinders' commonshaft (or the axes of the separate shafts) may be parallel to the lineconnecting between the pistons' axes through the common joint, such thatthe axis (or axes) of the cylinder shaft (or shafts), the lineconnecting between the pistons' axes through the common joint, and theaxes of the cylinders and of the pistons, may essentially form a trapezeshape.

The piston and cylinder mechanisms are described and illustratedthroughout this disclosure as motor driven linear actuator assemblies,with the activated rod being called the “piston”, and the thrust tube orouter housing being termed the “cylinder”, by analogy with a fluidoperated device. However, it is to be understood that although electricmotor actuated devices are generally understood to be the simplest andmost controllable implementations, it is possible to implement thedevices also using conventional pneumatic or hydraulic cylinders withtheir associated pistons. Therefore, the terms cylinders and pistonswhen used throughout this disclosure, and when claimed, are understoodto include any controllable linear motion-generating devices.

In some implementations, the end effector may be coupled to one of theat least one moveable platforms of the insertion device via one or moregimbals. For example, the end effector may be coupled to the moveableplatform by means of two gimbals; the first gimbal being located at itstop end and the second gimbal being located at its bottom end. In someimplementations, the first (top) gimbal may be coupled to the pistons'common joint via an axial joint, and the second (bottom) gimbal may becoupled to an extending arm member of the moveable platform via anotheraxial joint, such that propulsion of the pistons in and out of thecylinders results in rotation of the gimbal/s while the cylinders, thepistons, the pistons' common joint and the cylinder shaft/s all remainin a single plane.

The combination of the extending arm and piston mechanisms distances theend effector, and thus the needle coupled to the end effector, from themetallic components of the insertion device (e.g., motors and gears),and thus minimizes imaging artifacts in the area proximate the needle,which is scanned, in image-guided procedures, to follow and determinethe position of the needle during the insertion procedure.

In some implementations, the insertion device may have several degreesof freedom (DOF). For example, the device may have five DOFs:forward-backward and left-right linear translations, front-back andleft-right rotations, and longitudinal needle translation toward thesubject's body. In some implementations, the device may comprise a Zplatform, an X platform and a top assembly, the top assembly includingthe two piston mechanisms. The Z platform and the X platform may eachinclude a portion of a driving mechanism, such as a ball screwmechanism, which propels the X platform along the Z axis, on top of theZ platform. The X platform and the top assembly may each include aportion of another driving mechanism, which may also be a ball screwmechanism, which propels the top assembly along the X axis, which may beperpendicular to the Z axis, on top of the X platform. The combinationof the Z platform, the X platform and the top assembly thus enables fullplanar movement of the top assembly, and thus of the end effectorcoupled thereto. In some implementations, each piston mechanism of thetop assembly may include a cylinder and a piston which is moveable inand out of the cylinder, for example via a ball screw mechanism.Controlling the pistons' movements provides the device with tworotational DOFs. In some implementations, longitudinal needletranslation is enabled by means of an insertion mechanism, which may becoupled to the end effector or divided between the end effector and aninsertion module which is coupleable to the end effector and whichincludes the needle.

Although a linear needle trajectory is generally preferred, a lineartrajectory may not always be possible to plan, due to the location ofthe target (e.g., tumor, lesion), the presence of obstacles (e.g.,bones, blood vessels), etc., thus the planned trajectory may have acertain degree of curvature. Further, even if the planned trajectory islinear, it may not always be possible to follow the planned lineartrajectory due to movements of the target and/or the obstacles duringthe insertion procedure, for example. In such cases, the needletrajectory may be adjusted during the insertion procedure, as described,for example, in abovementioned U.S. Pat. No. 8,348,861.

In some implementations, the Remote Center of Motion (RCM) of the endeffector may be virtual and located at the needle entry point on thebody of the subject, i.e., the virtual RCM is not fixed by design, butchanges according to the chosen entry point. Once the needle entry pointis selected, the user may set the selected entry point as the virtualRCM. The system's software can then determine, using a reversekinematics algorithm, as described, for example, in abovementioned U.S.Pat. No. 8,348,861, the linear movements required from the X platformand/or the top assembly, while the end effector is being rotated, inorder to maintain the entry point as the virtual RCM. The virtual RCMbeing located at the needle's entry point prevents skin/tissue tearingif a linear trajectory is not possible to follow and/or if the plannedtrajectory (linear or otherwise) requires adjustment as the needle isbeing inserted into the patient's body.

In some implementations, the overall angular workspace of the needle mayform a cone shape, with its vertex being the virtual RCM, i.e., at theselected needle entry point.

There is thus provided in accordance with an exemplary implementation ofthe devices described in this disclosure, a an automated device forinserting a medical tool into a body of a subject, comprising:

(i) at least one moveable platform,

(ii) a first and a second piston mechanisms, each piston mechanismcomprising:

-   -   a cylinder,    -   a piston, at least a portion of the piston being positioned        within the cylinder, and    -   a driving mechanism configured to controllably propel the piston        in and out of the cylinder, and

(iii) an insertion mechanism configured to impart movement to themedical tool in the direction of the body of the subject,

wherein the distal ends of the pistons of the first and second pistonmechanisms are coupled to a common joint.

In such an automated device, the axes of the cylinders and of thepistons, and a line connecting the points of coupling of the pistonswith the common joint, may all be located substantially in a singleplane. The axes may be the longitudinal axes of the cylinders and of thepistons.

Further, in such an automated device, the distal ends of the pistons ofthe first and second piston mechanisms may be coupled to the commonjoint via piston end joints, each piston end joint having at least onerotational degree of freedom. In either of the above two devices, theproximal ends of the cylinders of the first and second piston mechanismsmay be coupled to a single shaft, also located in the single plane. Inthat case, the proximal ends of the cylinders may be coupled to thesingle shaft via cylinder end joints, each cylinder end joint having atleast one rotational degree of freedom.

Additionally, in alternative implementations of any of theabove-described, the at least one moveable platform may comprise:

(i) a first platform adapted to move in a first linear direction, and

(ii) a second platform coupled to the first platform and adapted to movein a second linear direction substantially perpendicular to the firstlinear direction, wherein the first and second piston mechanisms arecoupled to the second platform.

Furthermore, in any of these devices, the driving mechanism may comprisea threaded shaft and an internally threaded nut operatively coupled tothe threaded shaft and rigidly connected to the piston, such thatrotation of the threaded shaft results in linear movement of the piston.

Still other example implementations of the above described devices mayfurther comprise an end effector coupled to the common joint. The endeffector may be coupled to the common joint via a first gimbal, and thefirst gimbal may be coupled to the common joint via a rotational joint.

In any of the above described devices, the second platform may furthercomprise an extending arm and a second gimbal coupled to the extendingarm. At least a first portion of the insertion mechanism may then becoupled to the end effector. In the latter case, the device may furthercomprise an insertion module, the insertion module comprising themedical tool and at least a second portion of the insertion mechanism,the first portion of the insertion mechanism being configured foroperative coupling to the first portion of the insertion mechanism.

In any of the above described devices the automated device may comprisea virtual Remote Center of Motion located at a selected entry point onthe body of the subject, and then, the angular workspace of the medicaltool should form a cone shape, the vertex of the cone being located atthe virtual Remote Center of Motion.

Further implementations involve devices as previously described, furthercomprising at least one registration element. The previously describeddevices may further comprise a base adapted for securing to the body ofthe subject. In the latter case, the base may comprise a printed circuitboard, and the automated device may further comprise at least oneelectrical wire configured to connect the printed circuit board to atleast one additional printed circuit board of the at least one moveableplatform. The one or more of the at least one electrical wires may thencomprise a flat flex cable.

Yet other implementations may involve an automated device according toany of the above mentioned implementations, further comprising one ormore sensors configured to be coupled to one or more of the at least onemoveable platform, the first piston mechanism and the second pistonmechanism. In such a case, at least a first sensor of the one or moresensors may be configured to measure a parameter associated with theinteraction between the medical tool and a bodily tissue. The firstsensor may be a force sensor.

In any of the above described automated devices comprising sensors, atleast a second sensor of the one or more sensors may be configured tomonitor the movement of one or more of the at least one moveableplatform, the first piston and the second piston.

There is further provided, according to additional implementations ofthis disclosure, an automated device for inserting a medical tool into abody of a subject, comprising:

(i) a device base,

(ii) a first platform coupled to the device base and comprising a firstportion of a first driving mechanism,

(iii) a second platform coupled to the first platform and comprising:

-   -   a second portion of the first driving mechanism, the first        driving mechanism being configured to propel the second platform        in a first linear direction, and    -   a first portion of a second driving mechanism,

(iv) a third platform coupled to the second platform and comprising:

-   -   a second portion of a second driving mechanism, the second        driving mechanism being configured to propel the third platform        in a second linear direction substantially perpendicular to the        first linear direction, and first and second pistons connected        to a common joint at their distal ends, and

(v) an end effector coupled to the common joint and configured forcoupling the medical tool thereto.

In such automated devices, the axes of the first and second pistons anda line connecting the piston axes through the common joint, may belocated substantially in a single plane.

Such an automated device may further comprise an insertion modulecomprising the medical tool and configured to be coupled to the endeffector. Additionally, in such an automated device, the end effectormay comprise a first portion of a third driving mechanism and theinsertion module may comprise a second portion of the third drivingmechanism operatively coupleable to the first portion of the thirddriving mechanism, and the third driving mechanism may be configured toimpart movement to the medical tool in the direction of the body of thesubject.

In alternative further implementations, the automated device may furthercomprise:

(vi) first and second cylinders, wherein at least a portion of the firstpiston is positioned within the first cylinder, and at least a portionof the second piston is positioned within the second cylinder,

(vii) a fourth driving mechanism configured to controllably propel thefirst piston in and out of the first cylinder, and

(viii) a fifth driving mechanism configured to controllably propel thesecond piston in and out of the second cylinder.

In such a configuration, the proximal ends of the first and secondcylinders may be coupled to a single shaft, and the axes of the firstand second cylinders and of the single shaft may be located in thesingle plane. Furthermore, in any of these automated devices, the endeffector may be coupled to the common joint via a first gimbal, in whichcase the end effector may be further coupled to the second platform viaa second gimbal.

In any of the above described devices the automated device may comprisea virtual Remote Center of Motion located at a selected entry point onthe body of the subject.

The previously described devices may further comprise a base adapted forsecuring to the body of the subject. In the latter case, the base maycomprise a printed circuit board, and the automated device may furthercomprise at least one electrical wire configured to connect the printedcircuit board to at least one additional printed circuit board coupledto one or more of the first, second and third platforms. The one or moreof the at least one electrical wires may then comprise a flat flexcable.

Yet other implementations may involve an automated device according toany of the above mentioned implementations, further comprising one ormore sensors configured to be coupled to one or more of the firstplatform, the second platform, the third platform, the first piston, thesecond piston and the end effector. In such a case, at least a firstsensor of the one or more sensors may be configured to measure aparameter associated with the interaction between the medical tool and abodily tissue. In that case, the at least first sensor of the one ormore sensors may be configured to measure a parameter associated withthe interaction between the medical tool and a bodily tissue. The firstsensor may be a force sensor.

In any of the above described automated devices comprising sensors, atleast a second sensor of the one or more sensors may be configured tomonitor the movement of one or more of the first platform, the secondplatform, the third platform, the first piston and the second piston.

Implementations of the systems and devices described above may furtherinclude any of the features described in the present disclosure,including any of the features described hereinabove in relation to othersystem and device implementations.

It is to be understood that the terms proximal and distal as used inthis disclosure have their usual meaning in the clinical arts, namelythat proximal refers to the end of a device or object closest to theperson or machine inserting or using the device or object and remotefrom the patient, while distal refers to the end of a device or objectclosest to the patient and remote from the person or machine insertingor using the device or object.

It is also to be understood that although some examples used throughoutthis disclosure relate to systems and methods for insertion of a needleinto a subject's body, this is done for simplicity reasons alone, andthe scope of this disclosure is not meant to be limited to insertion ofa needle into the subject's body, but is understood to include insertionof any medical tool into the subject's body for diagnostic and/ortherapeutic purposes, including a port, introducer, catheter (e.g.,ablation catheter), cannula, surgical tool, fluid delivery tool, or anyother such insertable tool.

In addition, the terms “user”, “doctor”, “physician”, “clinician”,“technician”, “medical personnel” and “medical staff” are usedinterchangeably throughout this disclosure and may refer to any persontaking part in the performed medical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

Some exemplary implementations of the methods and systems of the presentdisclosure are described with reference to the accompanying drawings. Inthe drawings, like reference numbers indicate identical or substantiallysimilar elements.

FIG. 1 shows a schematic diagram of an exemplary system for inserting amedical tool into the body of a subject.

FIG. 2 shows a perspective view of an exemplary automated insertiondevice.

FIG. 3 shows an exploded view of an exemplary automated insertiondevice.

FIG. 4 shows a perspective view of an exemplary insertion device base.

FIG. 5 shows a perspective view of an exemplary robotic platform of anautomated insertion device.

FIGS. 6A-6B show perspective views of another exemplary robotic platformof an automated insertion device.

FIGS. 7A-7B show perspective views of an exemplary top assembly of anautomated insertion device.

FIG. 7C shows a top view of a common joint to which the pistons of thetop assembly of FIGS. 7A-7B are coupled.

FIG. 7D shows a longitudinal cross-sectional view of a piston mechanismof the top assembly of FIGS. 7A-7B.

FIG. 8 shows an exploded view of an exemplary insertion assembly.

FIG. 9 shows a transverse cross-sectional view of an exemplary automatedinsertion device, demonstrating the interfaces between the differentplatforms.

FIGS. 10A-10E depict an exemplary rotation range of an insertionassembly.

FIG. 11 depicts an overall angular workspace of an exemplary insertionassembly.

DETAILED DESCRIPTION

FIG. 1 shows a schematic diagram of a system 10 for inserting a medicaltool (e.g., needle) 110 into the body 15 of a subject. The systemincludes an automated insertion device 100, configured for steering theneedle during its insertion into the subject's body 15. The needle 110may be removably coupleable to the insertion device 100, such that theinsertion device 100 can be used repeatedly with new needles.

In some implementations, the system 10 may be configured to operate inconjunction with an imaging system, such that the insertion procedure isimage-guided. The utilized imaging modality may be any one of X-rayfluoroscopy, CT, cone beam CT, CT fluoroscopy, MRI, ultrasound, or anyother suitable imaging modality.

The insertion device 100 may be configured to be mounted directly on thesubject's body 15, as shown in FIG. 1, or it may be configured to becoupled to a dedicated arm or base which is secured to the patient'sbed, to a cart positioned adjacent the patient's bed or to the imagingdevice, as described, for example, in abovementioned U.S. patentapplication Ser. No. 15/027,438, and in U.S. patent application Ser. No.15/027,439, to Glozman et al, for “Gripper for Robotic Image GuidedNeedle Insertion”, both of which are incorporated herein by reference intheir entireties.

The system 10 further comprises a computer 130, including at least oneprocessor (not shown) for image processing, calculation of the optimalneedle insertion path, etc., and a display 131 on which the obtainedimages, the calculated insertion path, etc., can be displayed. Thecomputer 130 may be a personal computer (PC), a laptop, a tablet, asmartphone or any other processor-based device. The computer 130 mayalso include a user interface 132, which may be in the form of buttons,switches, keys, keyboard, computer mouse, joystick, touch-sensitivescreen, etc. The display 131 and user interface 132 may be two separatecomponents, or they may form together a single component, such as atouch-sensitive screen (“touch screen”).

The computer 130 may be configured, inter alia, to receive, process andvisualize on the display 131 images obtained from the imaging system (inDICOM format, for example), to calculate the optimal pathway for themedical tool, and to control needle steering, which may be executed in aclosed-loop manner, i.e., the processor may generate motion commands tothe insertion device 100 via the controller 120 and receive feedbackregarding the actual location of the tool, which is then used forreal-time pathway corrections. In some implementations, the optimalpathway may be calculated based on input from the user, such as theentry point, target and areas to avoid en route (also referred to as“obstacles”), which the user marks on at least one of the obtainedimages. In other implementations, the processor may be furtherconfigured to identify and mark the target, the obstacles and theoptimal entry point. The optimal pathway may be calculated in atwo-dimensional plane or in a three-dimensional space. In someimplementations the needle path may be calculated in a two-dimensionalplane, however, due to tissue movement, for example, the planned pathcannot be followed and it is also not possible to adjust the needle pathsuch that it remains in the same plane on which the original path wascalculated, such that the real-time pathway corrections are executed inthe three-dimensional space.

The system 10 further includes a controller 120, e.g., a robotcontroller, which controls the movement of the insertion device 100 andthe steering of the medical tool 110 towards the target (e.g., lesion ortumor) within the subject's body 15. Depending on the plannedtrajectory, needle steering may be carried out in a two-dimensionalplane or in a three-dimensional space. In some implementations, thecontroller 120 may be further configured to control the operation ofsensors (not shown), such as a force sensor and/or an accelerationsensor, implemented in the system 10. Use of sensor/s for sensingparameters associated with the interaction between a medical tool and abodily tissue, e.g., a force sensor, and utilizing the sensor data forguiding the insertion of the medical tool and/or for initiating imaging,is described, for example, in co-owned International Patent ApplicationNo. PCT/IL2016/051013 to Shochat et al, for “Systems and Methods forGuiding Insertion of a Medical Tool”, incorporated herein by referencein its entirety.

The controller 120 may be a separate component, as shown in FIG. 1.Alternatively, at least a portion of the controller 120 may be embeddedwithin the insertion device 100, and/or within the computer 130.

FIG. 2 shows a perspective view of an exemplary automated insertiondevice 20 having five degrees of freedom (DOF): linear translation alongthe Z axis (front-back) provided by a Z platform 230, linear translationalong the X axis (left-right) provided by an X platform 240, rotationabout the X axis (forward-backward) R₁, rotation about the Z axis(left-right) R₂, both rotations provided by a top assembly 250, andinsertion, i.e., longitudinal needle translation along the Y axis,provided by an insertion mechanism. The insertion mechanism may be partof an end effector (EEFF) 260, an insertion module (IM) 270 coupled tothe EEFF, or divided between the EEFF and the IM, as will be explainedin detail below.

The insertion device 20 may further comprise a base 220. In someimplementations, the insertion device 20 may be attached to thesubject's body directly, and accordingly, the base 220 may be providedwith straps (not shown in FIG. 2) and handles (or anchors) 222 forconnecting the straps to the base, with an adhesive layer (not shown) onthe bottom surface of the base 220, or with any other suitable means forattaching the base to the subject's body. In other implementations, theinsertion device 20 may be attached to the subject's body via adedicated mounting pad 225. The mounting pad 225 may be attached to thebottom of the device base 220 or to the bottom of a sterile drape (notshown in FIG. 2) which is used to cover the insertion device 20, atleast in part, or it may be positioned on the subject's body first andthen the insertion device 20, or more specifically—the base 220 of theinsertion device, is coupled to the mounting pad. The mounting pad maybe configured as a cushion, for example, to minimize any discomfort tothe patient resulting from attachment of the insertion device to his/herbody. In some implementations, if the insertion procedure is imageguided, the mounting pad 225 may include one or more fiducial markers(not shown), which form together an adjustable registration frame fordetermining the insertion device's position at any point during theprocedure if the device 20 outside the scanned volume, as described, forexample, in co-owned International Patent Application No.PCT/IL2016/051396 to Roth et al, for “Adjustable Registration Frame”,which is hereby incorporated by reference in its entirety. In furtherimplementations, the insertion device 20 may be attached to thesubject's body by coupling the device to a dedicated mounting base (orcradle) (not shown). Exemplary attachment devices are disclosed inco-owned U.S. International Patent Application No. PCT/IL2017/050430 toArnold et al, for “Devices and Methods for Attaching a Medical Device toa Subject”, which is hereby incorporated by reference in its entirety.

The insertion device 20 may further include at least one Printed CircuitBoard (PCB) 282 and electrical cables/wires 283 to provide electricalconnection between the controller and the motors and other electroniccomponents of the insertion device. In some implementations, at leastone of the electrical cables may be configured as a Flexible Flat Cable(FFC), e.g., FFC 284. Such a cable takes up less space and providesgreater flexibility and easier cable management. Further, in someimplementation, a single FFC may be used to provide electricalconnection between remote electronic components of the insertion device.In such a case, FFC 284, for example, may be folded and bent multipletimes between the different platforms of the device 20, toelectronically connect the base 220 with the top assembly 250. Thus, asingle FFC 284 may be used instead of numerous round cables, eliminatingwire coupling issues, taking up less space, and providing theflexibility required in a complex insertion device having severalbases/platforms, each moving in a different direction.

The insertion device 20 may further include fiducial markers (orregistration elements) 285 disposed at specific locations on the device,for registration of the device to the image space, in image guidedprocedures.

In some implementations, the insertion device 20 may include a housing(or cover) 290, which covers and protects, at least partially, themechanical and electronic components of the device 20 from being damagedor otherwise compromised.

FIG. 3 is an exploded view of the exemplary insertion device 20 of FIG.2, designated by numeral 30 in FIG. 3, showing the device base 320, theZ platform 330, the X platform 340, the top assembly 350, the endeffector 360 and the insertion module 370. In some implementations, thedevice base 320 may include at least part of the mechanism for attachingthe insertion device 30 to the subject's body, such as one or more strapanchors 322 to which one or more straps 325 are coupled by the user, orthe straps 325 themselves, which may be provided together with the base320. In some implementations, the device's cover (not shown in FIG. 3)may also include at least part of the attachment mechanism, such as thestrap anchors. The Z platform 330 may be coupled to the device base 320(e.g., using screws), and it may include at least part of the mechanismwhich enables the X platform 340 to move linearly along the Z axis ontop of the Z platform 330. The X platform 340 may include thecomplimentary part of the mechanism which enables it to move linearlyalong the Z axis, as well as at least part of the mechanism whichenables the top assembly 350 to move linearly along the X axis on top ofthe X platform 340. The top assembly 350 may include the complimentarypart of the mechanism which enables it to move linearly along the Xaxis, and it may further include the mechanism which enables the endeffector 360 to rotate. In some implementations, the end effector 360may be coupled to the top assembly via one or more gimbals 352 and 354.The end effector 360 may include a housing (or—frame) 362 for receivingthe insertion module 370, and it may further include at least part ofthe insertion mechanism, as will be explained in detail below. Theinsertion module 370 may include the insertion mechanism in itsentirety, or the complimentary part of the insertion mechanism, in casethe end effector 360 includes part of the insertion mechanism, and itmay further include the medical tool 310 to be inserted into thesubject's body. Such a medical tool may be a needle (e.g., a biopsyneedle), an introducer, a catheter etc. In some implementations, themedical tool 310 may be integral with the insertion module 370. In otherimplementations, the medical tool 310 may be separate from the insertionmodule 370, such that it is coupled to the insertion module 370 by amember of the medical staff prior to commencing the insertion procedure.

FIG. 4 shows a perspective view of an exemplary device base 40. The basemay include a base plate 410 for attaching to the subject's body, eitherdirectly or via a dedicated mounting pad or a mounting base (both notshown in FIG. 4). The base plate 410 may include a dedicated area, suchas in the form of a depression 412, for receiving and coupling theretothe Z platform (not shown in FIG. 4). The device base 40 may furtherinclude a plurality of anchors 420 to which straps/belts 425 may becoupled to secure the base 40 (and thus the insertion device) to thesubject's body. Alternatively, the straps/belts 425 may be coupled to amounting pad or mounting base to which the insertion device is thencoupled. The device base 40 may further include at least one PrintedCircuit Board (PCB) 430, which accommodates a plurality of the device'selectronic components, such as a CPU, and electrical wires, some ofwhich provide an electrical connection between the base PCB 430 andexternal components, such as cable 442 which may connect the base PCB430 to the controller (not shown in FIG. 4), and some of which connectbetween the base PCB 430 and other electronic components of theinsertion device, such as FFC 444 which provides electrical connectionbetween the base PCB 430 and the X platform PCB (not shown in FIG. 4).

The device base 40 may further include one or more registrationelements, such as fiducial markers 450, which are utilized in theprocess of registering the insertion device to the image space, in imageguided procedures.

FIG. 5 shows a perspective view of an exemplary Z platform 50 of theinsertion device. The Z platform 50 may be coupled to the device base(not shown in FIG. 5), such as by using a plurality of screws (notshown) and corresponding sockets 502, and it may include at least partof the driving mechanism which enables movement of the X platform (notshown in FIG. 5) on top of the Z platform 50 and along the Z axis. Insome implementations, the driving mechanism may include a ball screw(or—lead screw) mechanism. It can be appreciated that a ball screwmechanism is merely one example of a mechanism to propel the X platformalong the Z axis, and other suitable propulsion mechanisms may beimplemented instead or in addition.

In some implementations, the Z platform 50 may include a threaded shaft512, which is rotated by a motor 514 (e.g., a brushless electric motor)via a pinion 516 and gear 518, and the X platform may include, coupledto its bottom surface, an internally threaded nut (not shown in FIG. 5),such that the rotation of the threaded shaft 512 is transformed intolinear movement of the nut and therefore to linear movement of the Xplatform along the Z axis. In some implementations, the threaded shaftand nut may be provided preassembled as an integral unit, and the Xplatform may be secured to the threaded nut only after the preassembledshaft and nut (i.e., the ball screw mechanism) are secured to the Zplatform. However, it should be noted, that in the present disclosurethe shaft 512 is referred to as being part of the Z platform 50 and thenut is referred to as being part of the X platform, since the shaftremains stationary (though it does rotate) on the Z platform, whereasthe nut moves together with the X platform, as one piece.

The motor 514 may be provided with a rotational encoder, such asrotational magnetic encoder model IEM3-1024, manufactured by Faulhaberof Schonaich, Germany. The encoder may be provided separately from themotor or it may be provided as an integral part of the motor such thatboth the motor and its encoder are designated by numeral 514.

The Z platform 50 may further include one or more rails 520 which guidethe X platform's movement along the Z axis, e.g., via carriages (notshown in FIG. 5) which are attached to the bottom surface of the Xplatform and are configured to couple with the rails 520 such that theycan move freely along the rails 520. A linear encoder, e.g., linearmagnetic encoder model ID1101L manufactured by Posic Ltd. of Colombier,Switzerland, may be used to monitor the movement of the X platform alongthe Z axis. The encoder scale 525 may be positioned adjacent at leastone of the rails 520, and the encoder reader (not shown in FIG. 5) maybe coupled to the bottom portion of the X platform. A limit switch mayalso be utilized, in order to limit the travel of the X platform andprevent it from reaching the end of the rails, which may disrupt theproper function of the insertion device or even cause damage to the Xplatform and/or the rails. The limit switch may include a sensor 540,such as an opto-coupler having a light (e.g., infrared) source and alight detector positioned opposite each other, near each end of at leastone of the rails 520, and at least one sensor flag (not shown in FIG. 5)coupled to the bottom surface of the X platform, such that when the flagpasses between the light source and a light detector and blocks theemitted light from reaching the light detector, an alert may be promptedand/or the movement of the X platform may be automatically stopped. Itcan be appreciated that the limit switch implemented in the discloseddevice is not limited to an optical sensor, and other types of limitswitches, such as limit switches based on proximity sensors (magneticfield, capacitance, etc.) may also be used.

FIG. 6A shows a bottom perspective view of an exemplary X platform 60 ofthe insertion device. The X platform 60 may include, coupled to itsbottom surface, the internally threaded nut 602, which mates with thethreaded shaft of the Z platform. Rotation of the threaded shaft by themotor and gears of the Z platform is transformed into linear movement ofthe nut 602 and therefore of the X platform 60 along the Z axis. Alsoshown are the carriages 604 which mate with and slide along the rails ofthe Z platform so as to guide and direct the linear movement of the Xplatform 60 along the Z axis. The X platform 60 may further include,coupled to its bottom surface, the linear encoder reader 606, whichoperates in conjunction with the Z platform's encoder scale (not shownin FIG. 6A) to monitor the movement of the X platform 60 along the Zaxis, and the limit switch flag 608, which operates in conjunction withthe Z platform's limit switch sensor (not shown in FIG. 6A) to limit thetravel of the X platform and prevent it from reaching the end of the Zplatform's rails.

FIG. 6B shows a top perspective view of the X platform 60. The Xplatform 60 may include at least part of the driving mechanism whichenables movement of the top assembly (not shown in FIG. 6B) on top ofthe X platform 60 and along the X axis. In some implementations, thedriving mechanism may include a ball screw (or—lead screw) mechanism. Itcan be appreciated that a ball screw mechanism is merely one example ofa mechanism to propel the top assembly along the X axis, and othersuitable propulsion mechanisms may be implemented instead or inaddition.

In some implementations, the X platform 60 may include a threaded shaft612, which is rotated by a motor 614 (e.g., a brushless electric motor)via a pinion 616 and one or more gears 618 and 619, and the top assemblymay include, coupled to its bottom surface, an internally threaded nut(not shown in FIG. 6B), such that the rotation of the threaded shaft 612is transformed into linear movement of the nut and therefore of the topassembly along the X axis. In some implementations, the threaded shaftand the internally threaded nut may be provided preassembled as anintegral unit, and the top assembly may be secured to the threaded nutafter the preassembled shaft and nut (i.e., the ball screw mechanism) issecured to the X platform. However, it should be noted, that in thepresent disclosure the shaft 612 is referred to as being part of the Xplatform 60 and the nut is referred to as being part of the topassembly, since the shaft 612 moves together with the X platform, as onepiece, and the nut moves together with the top assembly, as one piece.

The motor 614 may be provided with a rotational encoder, such asrotational magnetic encoder model IEM3-1024, manufactured by Faulhaberof Schonaich, Germany. The encoder may be separate from the motor or itmay be provided integrally with the motor such that both the motor andits encoder are designated by numeral 614.

The X platform 60 may further include one or more rails 622 which guidethe top assembly's movement along the X axis, e.g., via carriages (notshown in FIG. 6B) which are attached to the bottom surface of the topassembly and are configured to couple with the rails 622 such that theycan move freely along the rails 622.

The combination of the Z and X platforms enables full planar movement ofthe top assembly.

A linear encoder, such as linear magnetic encoder model ID1101L,manufactured by Posic Ltd. of Colombier, Switzerland, may be used tomonitor the movement of the top assembly along the X axis. The encoderscale 625 may be positioned adjacent at least one of the rails 622, andthe encoder reader (not shown in FIG. 6B) may be coupled to the bottomportion of the top assembly. A limit switch may also be utilized, inorder to limit the travel of the top assembly and prevent it fromreaching the end of the rails 622, which may disrupt the proper functionof the insertion device or even cause damage to the top assembly and/orthe rails 622. The limit switch may include a sensor 644, such as anopto-coupler having a light source and a light detector positionedopposite each other, positioned near each end of at least one of therails 622, and at least one sensor flag (not shown in FIG. 6B) coupledto the bottom surface of the top assembly. It can be appreciated thatthe limit switch implemented in the disclosed device is not limited toan optical sensor, and other types of limit switches, such as limitswitches based on proximity sensors (magnetic field, capacitance, etc.)may alternatively be used.

The X platform 60 may further include at least one PCB 630 whichaccommodates a plurality of the X platform's electronic components, andelectrical wires. In some implementations, FFC 650, which provideselectrical connection between the PCB of the device base and the PCB ofthe top assembly, may be mechanically coupled to the X platform 60.

FIG. 7A shows a bottom perspective view of an exemplary top assembly 70of the insertion device. The top assembly 70 may include a base 700 tothe bottom surface of which the internally threaded nut 702, which mateswith the threaded shaft of the X platform, is coupled. Rotation of thethreaded shaft by the motor and gears of the X platform is transformedinto linear movement of the nut 702 and therefore of the top base 700and the entire top assembly 70 along the X axis. Also shown are thecarriages 704 which mate with and slide along the rails of the Xplatform, so as to guide and direct the linear movement of the topassembly 70 along the X axis. The top assembly 70 may further include,coupled to its bottom surface, the linear encoder reader 706, whichoperates in conjunction with the X platform's encoder scale (not shownin FIG. 7A) to monitor the movement of the top assembly 70 along the Xaxis, and the limit switch flag 708, which operates in conjunction withthe X platform's limit switch sensor (not shown in FIG. 7A) to limit thetravel of the top assembly 70 and prevent it from reaching the end ofthe X platform's rails.

FIG. 7B shows a top perspective view of the top assembly 70. The topassembly 70 may include a base portion 700 and an arm member 710extending from the base portion 700. The extending arm 710 may include,coupled to its distal end, a bottom gimbal 715, to which the device'send effector (not shown in FIG. 7B) is coupled. The bottom gimbal 715may be coupled to the arm member 710 via an axial joint 712, to allowrotation of the gimbal 715, and thus of the end effector, while the arm710 maintains its angular position. In some implementations, the topassembly arm 710 may include, coupled thereto, at least one registrationelement 717, which is utilized in the process of registering theinsertion device to the image space, in image guided procedures. Theregistration elements 717 may comprise tubes (or—rods) made of carbon,for example. In some implementations, the top assembly 70 may furtherinclude a force sensor (not shown) attached to the arm member 710, forexample, for measuring the forces exerted on the medical tool during itsinsertion into the subject's body. The real-time measurements of theforce sensor may provide one or more of: a gating function, i.e., theymay be used to define the optimal times/stages for initiating imaging ofthe region of interest, a monitoring and guidance function, i.e., theymay be used to monitor the progress of the insertion procedure andassist in verifying that the needle is following its preplannedtrajectory, and a safety function, i.e., they may be used to alert theclinician, and preferably also prompt automatic halt of the insertionprocedure, upon detecting that needle has hit/entered an obstacle, suchas a bone, a blood vessel, or the like, all as described inabovementioned International Patent Application No. PCT/IL2016/051013.

The top assembly 70 may further include piston mechanisms 720,positioned above the top assembly's base portion 700 and arm member 710.The arm member 710 and the piston mechanisms 720 distance the needle(not shown in FIG. 7B) from the metallic components of the device, suchas the motors and the gears, and thus minimizes the occurrence ofimaging artifacts in the area proximate the needle, which is scanned inorder to follow and determine the position of the needle during theinsertion procedure.

In some implementations, each piston mechanism 720 may include acylinder 722 and a piston 724 which is moveable in and out of thecylinder 722, for example via a ball screw mechanism. It can beappreciated that a ball screw mechanism is merely one example of amechanism to propel the piston in and out of the cylinder, and othersuitable propulsion mechanisms may be implemented.

In some implementations, each piston mechanism 720 may include a motor742, which rotates a threaded shaft (not shown in FIG. 7B) locatedwithin the cylinder 722, via a pinion 744 and a gear 746. The piston 724may include at its proximal end, which is located within the cylinder722, an internally threaded nut (not shown in FIG. 7B), which isoperatively coupled to the threaded shaft, such that rotation of thethreaded shaft is transformed into linear movement of the nut andtherefore of the piston in and out of the cylinder 722, as required. Themotor 742 may be provided with a rotational encoder 743 to monitor itsrotation.

In some implementations, the distal end of each piston 724 may becoupled to a separate joint having at least two rotational DOFs, andboth joints may be connected directly to the end effector (not shown inFIG. 7B). Such separate joints may be configured, for example, asball-and-socket joints, as cardan joints, or as any other suitablejoint. In other implementations, as shown from a perspective view inFIG. 7B and from a top view in FIG. 7C, the distal end joints 725 of thepistons 724 may be coupled to a common joint 726, which in turn iscoupled to a top gimbal 728, to which the device's end effector (notshown in FIGS. 7B and 7C) is coupled, in addition to its coupling to thebottom gimbal 715. In such implementations, the distal end joints 725may have one rotational DOF and the common joint 726 may have tworotational DOFs. Further, in such implementations, the distal end joints725 of the pistons and the proximal end joints 723 of the cylinders,which may comprise cardan joints, for example, and provide each cylinder722 with two DOFs, may be parallel to each other, such that thecylinders 722 and the pistons 724 may all be located on the same plane.An axial joint 727 connecting the top gimbal 728 to the common joint 726allows the cylinders 722, the pistons 724 and the common joint 726 toall remain on the same plane as the top gimbal 728 with the coupled endeffector are being rotated. The cylinders 722 and the pistons 724 allbeing located in a single plane allows also the horizontal axes of thecardan joints 723 of both cylinders 722 to be coupled to a single shaft(or—axle) 730, although in some implementations each cardan joint 723may be coupled to a separate shaft. This configuration, in which thecylinders 722, the pistons 724, the common joint 726 and the shaft 730are all located on the same plane, allows larger angular movement andthus a larger workspace of the end effector, without the limitations ofball-and-socket joints, for example, within a simple and compact design.It can be appreciated that although the top gimbal 728 and bottom gimbal715 shown in FIGS. 7A-7C have two arms for coupling the end effectorthereto, in some implementations either or both of the gimbals may haveonly one arm for coupling the end effector thereto, or they each mayhave any other suitable configuration suitable for coupling the endeffector thereto.

The top assembly 70 may further include one or more PCBs, for example, aPCB 719 may be attached to the top assembly's base portion 700 andadditional PCBs 729 may be coupled to each of the cylinders 722. Linearencoders, e.g., linear magnetic encoder model ID1101L manufactured byPosic Ltd. of Colombier, Switzerland, may be used to monitor themovement of the pistons 724 within the cylinders 722. The scales 7242 ofthe linear encoders may be coupled to the pistons 724, and the encoderreaders 7244 may be coupled to the cylinders 722. Limit switches 7246may also be utilized, in order to limit the travel of the piston 724 andprevent it from reaching the end of the threaded shaft.

FIG. 7D shows a cross-sectional view of one of the piston mechanisms ofFIGS. 7A-7B. As described above, each piston mechanism 720 may include acylinder 722 and a piston 724 which is moveable in and out of thecylinder 722 via a ball screw mechanism. Each piston mechanism 720 mayinclude a motor 742, which rotates a threaded shaft 748 located withinthe cylinder 722, via a pinion 744 and gear 746. The piston 724 mayinclude at its proximal end, which is located within the cylinder 722,an internally threaded nut 749, which is operatively coupled to thethreaded shaft 748, such that rotation of the threaded shaft 748 istransformed into linear movement of the nut 749, and thus of the piston724, in and out of the cylinder 722.

FIG. 8 shows an exploded view of an exemplary insertion assemblycomprising an end effector 80 and an insertion module 85. The insertionmodule 85 may include two flexible strips 852 coupled together alongtheir width, except in a region where they envelop the needle 855 attheir center line. The flexible strips 852 may have perforations 8522running along at least a portion of their length and on either side ofthe needle position along the centerline. The insertion module 85 mayfurther include rollers (not shown) having protrusions, such that theperforations 8522 of the strips 852 engage with the protrusions on therollers, and as the rollers counter-rotate in the appropriate direction,the double strip-needle assembly is forced in a distal direction, i.e.,towards the patient's body. The strips 852 then peel away from theneedle 855, and the needle 855 advances into the patient's body. Theinsertion module 85 may further include a needle head holder 858, whichsecures together the needle head 859 and the proximal end of the strips852.

The end effector 80 may comprise a frame 802 for receiving the insertionmodule 85. Once inserted into the frame 802, the insertion module 85 maybe locked therein using screws 804, for example, or any other suitablesecuring mechanism, such as snap-fit mechanism. The end effector 80 mayfurther include a motor assembly 810, which may include a geared motor812 (i.e., motor and planetary gear system) provided with a motorencoder (not shown), a bevel gear 814, and a PCB 816. The motor assembly810 may actuate the insertion mechanism as follows: the geared motor 812rotates the bevel gear 814, which in turn rotates a bevel gear 854 ofthe insertion module 85, to which it is coupled. The bevel gear 854 ofthe insertion module 85 then rotates the rollers of the insertion module85, and the counter-rotation of the rollers pulls downwardly the coupledstrips 852 via the “timing belt-like” mechanism comprised of therollers' protrusions and the strips' perforations.

In some implementations, the end effector's frame 802 may include adedicated slot 8022 for receiving the shaft 856 of the bevel gear 854 ofthe insertion module, such that the bevel gear 854 remains outside theframe 802 after the insertion module 85 is inserted therein, to enableits coupling to the bevel gear 812 of the end effector's motor assembly810.

The end effector 80 may further include one or more registrationelements 808, which may be coupled to its frame 802.

Further details and embodiments of the exemplary insertion assembly aredisclosed in co-owned International Patent Application No.PCT/IL2015/051158, to Galili et al, for “Needle Insertion Guide”,incorporated herein by reference in its entirety.

In some implementations, the insertion module 85 is a disposablesingle-use unit, and the end effector 80 is reusable, i.e., it can beused repeatedly with new disposable insertion modules 85. In such cases,the end effector 80 may be an integral unit of the insertion device. Inother implementations, the end effector 80 may also be disposable andthus provided separately from the automated insertion device. In suchcases the end effector 80 and the insertion module 85 may be provided asa single disposable unit.

FIG. 9 shows a transverse cross-sectional view of the insertion device90, demonstrating the interfaces between the different platforms. Asdescribed hereinabove, the movement of both the X platform along the Zaxis and the top assembly along the X axis may be propelled via a ballscrew mechanism. In addition, the linear movement of both the X platformand the top assembly may be guided via a rail-carriage mechanism. Z-Xplatforms: The Z platform 930 may include a threaded shaft 932 and the Xplatform 940 may include an internally threaded nut 948 which isoperatively coupled to the shaft 932. Rotation of the shaft 932 by amotor 934 and gear/s (not shown in FIG. 9) is transformed into linearmovement of the nut 948, and therefore of the X platform 940, along theZ axis. Further, the Z platform 930 may include one or more rails 936and the X platform 940 may include one or more corresponding carriages944 which are operatively coupled to the rails 936 and can move freely(or—slide) along the rails 936, to guide the linear movement of the Xplatform along the Z axis.

X platform—top assembly: The X platform 940 includes a threaded shaft942 and the top assembly 950 includes an internally threaded nut 958,which is operatively coupled to the shaft 942. Rotation of the shaft 942by a motor (not shown in FIG. 9) and gears 945 and 946 is transformedinto linear movement of the nut 958, and therefore of the top assembly950, along the X axis. Further, the X platform 940 may include one ormore rails (not shown in FIG. 9) and the top assembly 950 may includeone or more corresponding carriages (not shown in FIG. 9), which areoperatively coupled to the rails and can move freely (or—slide) alongthe rails, to guide the linear movement of the top assembly along the Xaxis. Also shown in FIG. 9 are the top assembly's cylinders 952 with thethreaded shafts 954 positioned therein.

FIGS. 10A-10D show the top assembly 1000 in four different statesdepicting an exemplary rotation range of the insertion assembly, i.e.,the EEFF and the IM, of the device.

FIG. 10A shows a side view of the top assembly 1000 with the insertionassembly 1100 at its maximal backward-directed rotation angle θ1, i.e.,the insertion assembly 1100 is maximally rotated about the X axis awayfrom the device. A backward angle is achieved by propelling both pistons1010 forward, out of the cylinders 1020, causing the needle head 1112 torotate forward and the needle tip 1110 to point backward, i.e., towardthe device. As shown, the manipulation of the needle, both its rotationand its insertion, is carried out at the coupling point/s of the topgimbal 1030 and the EEFF 1120, close to the patient's body, unlike priorart systems which generally manipulate the needle at the needle head.Since there is no need to generate the motion required for rotation andinsertion of the full length of the needle, which could be considerable,the workspace required by the disclosed insertion system issignificantly smaller than that of prior art systems. Further, thedevices of this disclosure are capable of driving needles of variablelengths while the dimensions and workspace of the driving mechanism donot depend on the length of the needles, as described in abovementionedU.S. patent application Ser. No. 15/027,438.

FIG. 10B shows a side view of the top assembly 1000 with the insertionassembly 1100 at its maximal forward-directed rotation angle θ₂=45°,i.e., the insertion assembly 1100 is maximally rotated about the X axistoward the device. A forward angle is achieved by propelling bothpistons 1010 backward, into the cylinders 1020, causing the needle head1112 to rotate backward and the needle tip 1110 to point forward, i.e.,away from the device.

FIG. 10C shows a top view of the top assembly 1000 with the insertionassembly 1100 at its maximal right rotation angle θ₃=45° (shown below inFIG. 10E), i.e., the insertion assembly 1100 is maximally rotated to theright about the Z axis (the direction “right” referring to the pagelayout). A right angle is achieved by rotating both cylinders 1020 a and1020 b to the right. Such rotation is achieved by propelling the leftpiston 1010 b further out of the left cylinder 1020 b than the rightpiston 1010 a is propelled out of the right cylinder 1020 b. Rotation ofthe insertion assembly 1100 to the right causes the needle head 1112 torotate to the right, such that the needle tip 1110 points to the left.

FIG. 10D shows a top view of the top assembly 1000 with the insertionassembly 1100 at its maximal left rotation angle θ₄=45° (shown below inFIG. 10E), i.e., the insertion assembly 1100 is maximally rotated to theleft about the Z axis. A left angle is achieved by rotating bothcylinders 1020 a, 1020 b to the left. Such rotation is achieved bypropelling the right piston 1010 a further out of the right cylinder1020 a than the left piston 1010 b is propelled out of the left cylinder1020 b. Rotation of the insertion assembly 1100 to the left causes theneedle head 1112 to rotate to the left, such that the needle tip 1110points to the right.

As shown in FIGS. 10A-10D, as the insertion assembly 1100 is beingrotated throughout its entire rotation range, the top assembly's armmember 1050 remains stationary and the cylinders 1020 a and 1020 b, thepistons 1010 a and 1010 b, the shaft 1025 and the common joint 1060 allremain on the same plane.

FIG. 10E demonstrates the maximal right and left rotation angles, θ₃ andθ₄ respectively, of the insertion assembly of FIGS. 10C and 10D. Alsoshown are the locations 1090A, 1090B and 1090C of the top gimbal whenthe needle is parallel to the Y axis and when the insertion assemblyreaches its maximal right and left rotation angles, respectively. Thetop gimbal's trajectory between the maximal right and left rotationangles forms an arc on the X-Y plane. It can be appreciated that the topgimbal's trajectory as the insertion assembly is being rotated betweenthe maximal forward angle and the maximal backward angle also forms anarc, on the Z-Y plane.

It is to be understood, that although in FIGS. 10A-10E the maximalneedle rotation angles are θ₁=θ₂=θ₃=θ₄=45°, this is done for simplicityreasons alone. The maximal rotation angles θ₁, θ₂, θ₃ and θ₄ are notnecessarily equal to each other. Further, they are not limited to 45°,and each may be higher or lower than 45°.

FIG. 11 depicts the overall workspace 1200 of the longitudinal axis ofthe insertion assembly 1100 having two rotational degrees of freedom,the first depicted in FIGS. 10A-10B and the second depicted in FIGS.10C-10E. In some implementations, the Remote Center of Motion (RCM) ofthe insertion assembly 1100 may be virtual and located at the needle'sentry point. Although the rotation axis of the insertion assembly islocated at the bottom gimbal of the device's top assembly, as shown inFIG. 10E, the location of the virtual RCM is maintained at the needle'sentry point via linear movements of the X platform along the Z axisand/or of the top assembly along the X axis.

Once the needle entry point is selected, the user may set the selectedentry point as the virtual RCM. The system's software can thendetermine, using a reverse kinematics algorithm, as described, forexample, in abovementioned U.S. Pat. No. 8,348,861, the linear movementsrequired from the X platform and/or the top assembly, while theinsertion assembly is being rotated, in order to maintain the entrypoint as the virtual RCM. The virtual RCM being maintained at the needleentry point prevents skin/tissue tearing in case a linear needletrajectory is not possible to follow and/or if the planned trajectory(linear or otherwise) requires adjustments as the needle is beinginserted.

The workspace 1200 may form a cone shape, with its vertex 1500, beingthe virtual RCM, located at the needle's entry point. It can beappreciated that the insertion assembly's workspace is not necessarilysymmetrical in all axis. If the maximal rotation angles are identicalabout all axis, e.g., as shown above in FIGS. 10A-10E, then theworkspace is symmetrical about all axis, as shown in FIG. 11, i.e., thetransverse cross-section of the formed cone is a circle. However, if themaximal rotation angles about the X axis are different from the maximalrotation angles about the Z axis, e.g., θ₁=θ₂=45° and θ₃=θ₄=55°, thetransverse cross-section of the formed cone is an ellipse. In someimplementations, the maximal rotation angles may differ in eachdirection. Further, the angular workspace is not necessarily equal tothe rotation about X axis and to the rotation about the Z axis, suchthat the workspace may be, for example, rectangular.

Although particular implementations have been disclosed herein indetail, this has been done by way of example for purposes ofillustration only, and is not intended to be limiting with respect tothe scope of the appended claims, which follow. In particular, it iscontemplated that various substitutions, alterations, and modificationsmay be made without departing from the spirit and scope of thedisclosure as defined by the claims. Other aspects, advantages, andmodifications are considered to be within the scope of the followingclaims. The claims presented are representative of the implementationsand features disclosed herein. Other unclaimed implementations andfeatures are also contemplated. Accordingly, other implementations arewithin the scope of the following claims.

The invention claimed is:
 1. An automated device for inserting a medicaltool into a body of a subject, comprising: a device base; a firstplatform coupled to said device base and comprising a first portion of afirst driving mechanism; a second platform coupled to said firstplatform and comprising: a second portion of said first drivingmechanism, said first driving mechanism comprising at least a firstmotor and being configured to propel said second platform in a firstlinear direction; and a first portion of a second driving mechanism; athird platform coupled to said second platform and comprising: a secondportion of said second driving mechanism, said second driving mechanismcomprising at least a second motor and being configured to propel saidthird platform in a second linear direction substantially perpendicularto the first linear direction; and first and second pistons connected toa common joint at their distal ends; and an end effector coupled to saidcommon joint and configured for coupling said medical tool thereto. 2.The automated device according to claim 1, wherein axes of said firstand second pistons and a line connecting said piston axes through saidcommon joint, are located substantially in a single plane.
 3. Theautomated device according to claim 2, further comprising: first andsecond cylinders, wherein at least a portion of said first piston ispositioned within the first cylinder, and at least a portion of saidsecond piston is positioned within the second cylinder; a fourth drivingmechanism configured to controllably propel said first piston in and outof the first cylinder; and a fifth driving mechanism configured tocontrollably propel said second piston in and out of the secondcylinder.
 4. The automated device according to claim 3, wherein proximalends of said first and second cylinders are coupled to a single shaft,and wherein axes of said first and second cylinders and of said singleshaft are located in said single plane.
 5. The automated deviceaccording to claim 4, wherein said proximal ends of said first andsecond cylinders are coupled to said single shaft via cylinder endjoints, each cylinder end joint having at least one rotational degree offreedom.
 6. The automated device according to claim 3, wherein each ofsaid fourth and fifth driving mechanisms comprises: a threaded shaft; aninternally threaded nut operatively coupled to said threaded shaft andrigidly connected to a piston of said first and second pistons, whereinrotation of said threaded shaft results in linear movement of saidpiston of said first and second pistons.
 7. The automated deviceaccording to claim 1, further comprising an insertion module configuredfor receiving said medical tool and for coupling to said end effector,to couple said medical tool to said end effector.
 8. The automateddevice according to claim 7, wherein said end effector comprises a firstportion of a third driving mechanism and said insertion module comprisesa second portion of said third driving mechanism, operatively coupleableto said first portion of said third driving mechanism, wherein saidthird driving mechanism comprises at least a third motor and isconfigured to impart movement to said medical tool in the direction ofthe body of the subject.
 9. The automated device according to claim 8,wherein said first portion of said third driving mechanism comprisessaid third motor, and said second portion of said third drivingmechanism comprises two rollers, and wherein upon said medical toolbeing received by said insertion module, said medical tool is disposedbetween said two rollers, such that counter-rotation of said two rollersby said third motor results in linear movement of said medical toolbetween said two rollers.
 10. The automated device according to claim 1,wherein said distal ends of said first and second pistons are coupled tosaid common joint via piston end joints, each piston end joint having atleast one rotational degree of freedom.
 11. The automated deviceaccording to claim 1, further comprising a first gimbal, and whereinsaid end effector is coupled to said common joint via said first gimbal.12. The automated device according to claim 1, wherein said secondplatform further comprises an extending arm and a second gimbalconfigured for coupling said end effector to said extending arm.
 13. Theautomated device according to claim 1, wherein said first portion ofsaid first driving mechanism comprises said first motor and a firstthreaded shaft, and said second portion of said first driving mechanismcomprises a first internally threaded nut configured to receive thereinsaid first threaded shaft, such that rotation of said first threadedshaft by said first motor results in linear movement of said secondplatform.
 14. The automated device according to claim 1, wherein saidfirst portion of said second driving mechanism comprises said secondmotor and a second threaded shaft, and said second portion of saidsecond driving mechanism comprises a second internally threaded nutconfigured to receive therein said second threaded shaft, such thatrotation of said second threaded shaft by said second motor results inlinear movement of said third platform.
 15. The automated deviceaccording to claim 1, further comprising one or more sensors coupled toone or more of said first platform, said second platform, said thirdplatform, said first piston, said second piston and said end effector.16. The automated device according to claim 15, wherein at least a firstsensor of said one or more sensors is configured to measure a parameterassociated with an interaction between said medical tool and a bodilytissue.
 17. The automated device according to claim 15, wherein at leasta second sensor of said one or more sensors is configured to monitormovement of one or more of said first platform, said second platform,said third platform, said first piston and said second piston.
 18. Theautomated device according to claim 1, further comprising at least oneregistration element.
 19. The automated device according to claim 1,wherein the device base is configured for securing to the body of thesubject.
 20. The automated device according to claim 1, furthercomprising a mounting base configured for securing to the body of thesubject and for coupling said device base thereto.